Orchestra BioMed (Nasdaq:OBIO) announced today that it began the rollout of a protocol update for its BACKBEAT study.
The FDA approved the protocol update, significantly expanding patient eligibility criteria for enrollment in the study. BACKBEAT evaluates the company’s atrioventricular interval modulation (AVIM) therapy. It looks at AVIM in pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications.
New Hope, Pennsylvania–based Orchestra won FDA breakthrough device designation for its AVIM therapy earlier this year. It uses conduction system pacing to immediately, substantially and persistently reduce blood pressure. The patented bioelectronic therapy comes through standard dual-chamber pacemaker.
Key updates include patients with Medtronic Astra or Azure dual-chamber pacemakers. This includes those devices with sufficient battery life implanted for any reason and those that are first device implants or implanted to replace an existing pacemaker. The new protocol also includes New York Heart Association (“NYHA”) class I or class II symptomatic heart failure.
Orchestra BioMed expects the protocol update to increase its eligible patient pool for BACKBEAT by more than 24-fold. It supports the company’s target of mid-2026 enrollment completion.
This marks the latest good news for Orchestra, which earlier this week completed strategic transactions and equity offerings worth an expected $111.2 million.
“These expanded eligibility criteria significantly increase the pool of potentially eligible patients available for enrollment in the BACKBEAT study at participating study centers,” said David Hochman, chair and CEO of Orchestra BioMed. “We believe these updates reinforce the relevance and potential impact of the BACKBEAT study as well as better position us to complete the BACKBEAT study in a timely manner.”
